David Tuller was a reporter and editor for ten years at the San Francisco Chronicle. He served as health editor at Salon.com and frequently writes health stories for the New York Times. He received his masters in public health at Berkeley in 2005.

Reprinted with the kind permission of David Tuller. This article was originally published on BuzzFeed.

By David Tuller

Ten years ago, Jeannette Burmeister was working full throttle, logging 80-hour weeks as an attorney specializing in international commercial and employment law at the San Francisco area offices of a major law firm. So when she developed a sinus infection over the Christmas holidays in 2005, she assumed she’d bounce right back.

But she didn’t. The illness persisted; Burmeister then began suffering from profound lapses of energy, crippling problems with concentration and memory, and severe sleep disorders, among other symptoms.

“I went to work for two hours one day, hit a wall, and couldn’t go back the next day,” Burmeister, now 42, said in a recent telephone conversation. “I could not think straight. I had days where I couldn’t spell my name. And such complete exhaustion you can’t describe it, like you just ran a marathon, are hungover, and have the flu, all at once.”She hadn’t heard of chronic fatigue syndrome until a friend mentioned it; when she looked it up, the symptoms seemed to fit. As with many people who have the illness, a battery of tests found that Burmeister had abnormally high levels of antibodies to a variety of common viruses, including Epstein-Barr virus, human herpesvirus 6, parvovirus, and coxsackievirus. The significance and meaning of such findings are not fully understood; people without the illness can also have elevated viral levels.

Photo: Paul Chinn, The Chronicle

Burmeister said the disease — and its trivial-sounding moniker — has isolated her from former friends and

acquaintances. They don’t understand how sick she is, she said, and she recognizes that explaining it to them is often futile. “First of all you’ve got the name,” she said. “And once you’ve put the name out there you’ve already lost most people’s attention, because then they say, ‘Yeah, I have a hard job,’ or, ‘I’m tired too.’”

More than 1 million Americans suffer from chronic fatigue syndrome, according to the Centers for Disease Control, although many experts believe that the agency’s figures are somewhat inflated. The illness is also known as “myalgic encephalomyelitis,” which means “painful inflammation of the brain and spinal cord,” and many people now refer to it as ME/CFS. Patients are used to having their symptoms belittled as imaginary or dismissed as a manifestation of depression by family, friends, colleagues, and doctors — even though compelling evidence has linked the complex illness to major immunological, neurological, and cognitive dysfunctions. Experts now believe that ME/CFS is likely a cluster of closely related conditions, triggered when an acute infection, or some other physiological insult such as exposure to environmental toxins or mold, kicks the immune system into a prolonged state of hyperactivation.

No drugs have been approved for ME/CFS, but Burmeister has found partial relief in recent years with twice-weekly infusions of the drug Ampligen, an unapproved immunomodulator that she can only obtain through an experimental treatment protocol. She blogs extensively about her illness and in 2012 testified before a Food and Drug Administration panel considering whether to recommend approval for Ampligen. (The panel voted 8-5 against it, citing insufficient safety and efficacy data.)

Jeannette Burmeister at IOM on Jan 27

In recent months, her blog has doggedly tracked the creation of a new, federally commissioned panel charged with reviewing and updating the diagnostic criteria for the disease. The Department of Health and Human Services announced in September that it had requested the Institute of Medicine, an independent, highly regarded affiliate of the National Academy of Sciences, to conduct the study. At a public hearing in Washington, D.C., on Monday, Jan. 27, Burmeister plans to tell the members of the panel why she thinks their project stinks.

Few would claim that describing an illness with enough accuracy for clinicians to recognize it and treat it effectively is simple. But for most illnesses, creating diagnostic criteria — known as a clinical case definition — is not the stuff of high drama and conflict. ME/CFS, however, is not most illnesses.

To those who aren’t sufferers, chronic fatigue syndrome often sounds like it’s just stress related or psychosomatic — and ME/CFS has often been framed that way by medical professionals in the past. Now, Burmeister and other patients, clinicians, and researchers fear that the new, 15-member panel could repeat that mistake.

In general, medical experts in a particular illness or condition debate and create clinical case definitions and guidelines. But no single medical specialty claims ME/CFS. Patients often see clinicians in a range of specialties, including infectious diseases, immunology, neurology, rheumatology, and psychiatry. The closest parallel to a traditional medical society is the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, a scientific and advocacy organization of researchers, health care professionals, and others.

Dr. Ellen Clayton, IOM chair

So when the Institute of Medicine announced provisional members of the panel last month, many patients were angry that more than half of the members — whatever their accomplishments in their own fields — were not known to have any professional expertise in ME/CFS. Many clinicians and researchers with experience in the field have already endorsed a set of diagnostic criteria that they say should be used as the starting point for any new case definition.

“I can’t imagine any other field where this would be happening,” said Burmeister, who grew up in East Germany, moved to the U.S. in 1999, and became a citizen in 2012. “You wouldn’t have rocket scientists come up with guidelines for heart surgery. To have a majority of nonexperts on the committee — of course this is crazy.”

The Ripple Effect

A broad or imprecise definition of the illness could have a ripple effect. Patients like Burmeister fear that flawed results will undermine research into organic causes and lead to treatments more appropriate for depression and other psychiatric conditions than for their illness.

Last fall, several dozen top researchers and clinicians in the ME/CFS field signed an unusual letter of protest to Kathleen Sebelius, secretary of the Department of Health and Human Services, strongly urging her to abandon the IOM initiative. Dr. Daniel Peterson, one of the letter-signers and a well-known expert who has treated ME/CFS patients in Incline Village, Nev., for three decades, echoed Burmeister’s concerns about the role of the nonexperts on the IOM panel.

“If I were redefining the criteria for diabetes, I would certainly want 25 diabetologists to render their opinion,” said Peterson. “I wouldn’t want neurosurgeons and psychiatrists and people who have never seen a patient. I can’t imagine being on a committee for some disease I don’t know about.”

In the letter, the experts also criticized the health department’s decision to spend $1 million on the IOM project, given that the National Institutes of Health only spends $5 million annually in research on the disease, far less than it devotes to many less common illnesses.

“Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease,” wrote the experts. “Worse, this effort threatens to move…science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.

Dharam Ablashi

One letter-signer, Dharam Ablashi, a prominent former researcher at the National Cancer Institute and currently scientific director of the HHV-6 Foundation, chided the federal agency. “Why do you want to spend $1 million to reinvent something?” he said. “The key point is, there are criteria out there that are working — they’re not perfect, but they can be modified.”

The Office on Women’s Health at the Department of Health and Human Services, which is co-sponsoring the IOM project, responded to questions by referring to previously issued department statements, which noted that the institute is an appropriate venue for resolving such thorny issues and that its imprimatur would ensure maximum acceptance and credibility for the findings.

“The IOM has a singular reputation for providing biomedical recommendations on difficult, complex and controversial questions in medicine,” read a FAQ from the department about the project. “The IOM process of developing consensus recommendations is widely accepted by professional societies and other medical institutions that disseminate clinical guidelines.”Two Perspectives: Cooperation vs Resistance

Not all patients and experts oppose the IOM initiative, and the issue of whether it is possible to cooperate with the panel and not be co-opted by it has been vigorously debated on social media. The CFIDS Association of America, a major ME/CFS organization that has frequently been at odds with grassroots patient advocates, has again caused grumbling in some quarters because of its support for the health department’s IOM agreement. Some signers of the experts’ letter have also been invited to join the IOM panel, and have accepted. Moreover, the panel appears to contain more acknowledged ME/CFS experts than many people had expected — seven out of the 15 members, if early reports are accurate.

Carol Head, president and CEO of the CFIDS Association of America, said she understood the concerns of those who oppose the IOM’s involvement but noted that no one medical specialty owns the illness. “It lacks an established medical society as exists in other diseases, so it made sense to us that the IOM would be a place to start with this,” she said.

The panel is expected to deliver its report in a year, and its guidelines are likely to be widely disseminated and accepted by doctors, so the stakes for patients are high. With any disease, accurate case definitions for both research and clinical care are essential. A case definition that is drawn too loosely and thereby includes too many people who do not have the illness in question will skew research findings and lead to unjustified and potentially harmful treatment recommendations. And case definitions that are too narrow end up screening out people with the illness who need treatment but might not be identified because of atypical disease presentation.

For diseases with reliable tests for biomarkers that indicate the presence of an infection or other abnormal physiological phenomenon, a positive result might be all that is needed for an accurate case definition. But for conditions identified through symptoms, like Gulf War Illness and ME/CFS, creating a case definition that includes those with the illness while excluding those without it is far more difficult, especially if some of the symptoms are non-specific and subjective.

In particular, ME/CFS and depression can resemble each another; a loose case definition might end up including people whose primary complaint is depression, not ME/CFS. So it is important but challenging to determine whether depression caused the fatigue and other symptoms or if the patient is depressed because that patient is indeed very sick.

Leonard Jason

Leonard Jason, a professor of psychology at DePaul University in Chicago and a widely respected ME/CFS researcher, said that a good strategy for distinguishing between the illness and depression is to ask patients what they would do if they suddenly recovered. Those suffering from a major depressive disorder, he said, would likely say they didn’t know. “But someone with ME/CFS would probably begin making lists of all the things that they wanted to do,” he said.

A History of Conflict and Condescension

Mistrust and conflict between chronic fatigue syndrome patients and federal health officials has a long history, as Hillary Johnson documented in 1996 in Osler’s Web: Inside the Labyrinth of the Chronic Fatigue Syndrome Epidemic, a prodigious feat of investigative reporting. When several outbreaks of a persistent, flu-like illness occurred around the U.S. in the mid-1980s, many suspected Epstein-Barr virus as the culprit. The Centers for Disease Control investigated, identified no causal agent, and ultimately saddled the condition with the unfortunate and condescending name — even though the essentially identical illness known as benign myalgic encephalomyelitis (or just myalgic encephalomyelitis) had been identified many years earlier.

In the late 1990s, the CDC was found to have diverted millions of dollars intended for CFS research into other disease programs, and then to have lied to Congress about it. In the 2000s, the agency further enraged patients when it refused to support a movement to change the name to myalgic encephalomyelitis and instead spent millions on an awareness campaign promoting the name “chronic fatigue syndrome.” Patients have also long complained that the agency has focused more on psychological issues than on possible organic causes. In 2010, for example, the CDC published a study that characterized people with the illness as suffering disproportionately from “maladaptive personality features” — compared with a control group, the ill subjects had higher “scores on neuroticism” and higher rates of “paranoid, schizoid, avoidant, obsessive-compulsive, and depressive personality disorders.”

In fact, two-thirds of patients report that their downward slide started with an acute illness, such as mononucleosis or the flu, that never seemed to resolve. And experts and patients agree that the word “fatigue” causes a great deal of misunderstanding among those unfamiliar with the illness. A cardinal symptom, they say, is not just fatigue per se, but what is called post-exertional malaise or post-exertional relapse — the inability of the body to recover rapidly from even small expenditures of energy. Research in recent years has confirmed the presence of this unusual symptom among people with ME/CFS. Moreover, the exhaustion they report is far more severe than the garden-variety tiredness implied by “fatigue.”

Patients despise the name, said Michael Allen, a psychologist who became ill in the early 1990s. “When I hear that word, it makes me nuts, like waving a red flag in front of a bull,” said Allen, who lives in San Francisco. “Normal fatigue is when you’ve just run five miles and you’re tired and you take a nap and the fatigue is gone. But I have days where I’m lying on the couch for hours and I literally can’t move, like I just had major surgery. Like the mitochondria in the cells of my muscles and brain have just stopped producing energy.”

In a blog post this month at Oxford University Press, Leonard Jason, the DePaul psychology professor, described some possible impacts of the poorly chosen name.

“Chronic fatigue syndrome is an illness as debilitating as Type II diabetes mellitus, congestive heart failure, multiple sclerosis, and end-stage renal disease,” wrote Jason. “Yet 95% of individuals seeking medical treatment for CFS reported feelings of estrangement; 85% of clinicians view CFS as a wholly or partially psychiatric disorder; and hundreds of thousands of patients cannot find a single knowledgeable and sympathetic physician to take care of them. Patients believe that the name CFS has contributed to health care providers as well as the general public having negative attitudes toward them.”

Burmeister concurs with that point wholeheartedly, citing a recent visit to the emergency room after her car was rear-ended. “I was very careful not to mention CFS or ME during check-in, because patients have been known to get abused with that diagnosis in the file,” she said. She knows she is lucky to have a supportive husband who has not questioned the reality of her illness. “He never doubted me, and that’s rare — a lot of patients go through divorces,” she said.

Nonetheless, they live separately, although not because they want to. Only a handful of doctors around the country are willing to submit to the cumbersome protocol requirements for administering Ampligen; one of them is Peterson in Incline Village, which is on Lake Tahoe. Traveling back and forth twice a week to receive her infusions seemed too exhausting, so for the foreseeable future she is living in Incline Village most of the time; her husband Ed, also a lawyer with a major law firm, and 3-1/2-year-old daughter, Aimee, live in Menlo Park, south of San Francisco. Burmeister feels the medication regimen allows her to function at a modest level, although she still must guard against overexerting herself.

Being able to see Aimee only once every couple of weeks is heartbreaking. “I would like to be able to be a real mother, to take her on play dates and to the playground,” she said wistfully. “We Skype and talk on the phone, but that’s not the same as being with her. She’s definitely more attached to my husband, which is hard for any mother. I deal with it mostly by compartmentalizing — otherwise it’s too painful to think about.”

The IOM and the Case Definition for ME/CFS

The recent round of activity involving case definitions began in fall 2012, when the Chronic Fatigue Syndrome Advisory Committee — a body created under the auspices of the Department of Health and Human Services to provide guidance on the issue — recommended that the agency convene a workshop to nail down definitive case definitions for both clinical care and research.

Over the years, researchers and clinicians around the world have created at least half a dozen different case definitions for ME/CFS, based on their understandings at the time. In 1994, the Centers for Disease Control developed what became the most widely used criteria. It required the presence of six months of unexplained fatigue, plus any four of eight symptoms: cognitive problems, sore throat, tender lymph nodes, muscle pain, joint pain, headaches, sleep disorders, and post-exertional malaise.

In 2003, researchers and clinicians developed a more rigorous case definition widely known as the Canadian Consensus Criteria. In addition to fatigue, this definition requires the presence of all symptoms that experts recognized as hallmarks of the illness: post-exertional malaise, sleep disorders, muscle and joint pain, and evidence of neurological or cognitive problems. The Canadian Consensus Criteria is therefore considered by many to be the most accurate case definition and is now often used by clinicians for diagnosis — although there is general agreement that it needs further updating and refinement.

The 2012 recommendation of the Chronic Fatigue Syndrome Advisory Committee to the Department of Health and Human Services included two key elements: that the workshop to develop the research and clinical case definitions should be for stakeholders in the ME/CFS field, specifically doctors, researchers, and patients, and that it should adopt the Canadian criteria as the starting point for making adjustments.

To advisory committee members who supported the recommendation, the health department’s decision to engage the IOM instead felt like a slap in the face. And rather than designating the Canadian criteria as the basis for modifications, the health department charged the panel with assessing a full range of existing case definitions. (The Department of Health and Human Services also decided to pursue a completely separate process for developing a second case definition appropriate for research and examining other research-related issues.)

Mary Ann Fletcher, a member of the Chronic Fatigue Syndrome Advisory Committee who strongly supported the recommendation for a committee of experts, said she was totally baffled by the health department’s action. “This was not ever our recommendation, so I really can’t explain why they took us there,” said Fletcher, a professor at Nova Southeastern University in Fort Lauderdale and a leader in immunology research related to ME/CFS.

The protest letter from the leading experts to Secretary Sebelius, in addition to registering overall objections to the IOM effort, also identified the Canadian criteria as the appropriate basis for further refinements. In her response to the experts’ letter, Sebelius wrote that the IOM approach “was determined to be the most appropriate response” to the Chronic Fatigue Syndrome Advisory Committee’s recommendation. She also noted that the Canadian criteria would be considered, along with others.

The Department of Health and Human Services referred questions about selection and composition of the panel to the IOM. In an email, a spokeswoman for the institute stated that it had pursued the same strategy for ensuring the selection of disinterested panel members that it always uses for its investigations.

But many people with ME/CFS are especially concerned because of an IOM report produced last year under a contract with the Veterans Administration on treatments for Gulf War Illness — now renamed “chronic multisymptom illness.” By focusing extensively on stress-related factors and recommending cognitive behavior therapy and antidepressants as the key forms of treatment, the report caused controversy and drew complaints from veterans.

Under the Freedom of Information Act, Burmeister has requested documents relating to the IOM project and the institute’s contract with the Department of Health and Human Services, hoping they would shed light on the federal agency’s decisions and intentions. So far she has not received them, which is not unusual; federal agencies often take years before producing actual documents in response to such requests. Undaunted, Burmeister this month filed a lawsuit against the department charging it with violating the Freedom of Information Act.

Whatever the IOM panel decides when it delivers its report, Burmeister believes it is unlikely that she herself will ever recover fully. She misses her past life; she used to exercise five days a week at the gym and loved going out dancing. If she were better, she said, she might start a law firm with her husband to protect the rights of people with disabilities — a cause that she has come to embrace.

As it is, she plans to fight for people with ME/CFS as long as her health allows. “So many friends with this are sicker than I am and can’t do what I’m doing,” she said. “So this is something that’s close to my heart, that has given me a purpose again.”

Below is a post which appeared on the OUP blog last week. Leonard Jason is a professor of psychology at DePaul University in Chicago, Illinois, where he also directs the Center for Community Research. Since the mid-1990s, he has published more than 60 papers on ME/CFS. Dr. Jason is best known for his epidemiological studies of the disorder, for which he has received many honors and awards.

Names of diseases have never required scientific accuracy (e.g. malaria means bad air, lyme is a town, and ebola is a river). But some disease names are offensive, victim-blaming, and stigmatizing. Multiple sclerosis was once called hysterical paralysis when people believed that this disease was caused by stress linked with oedipal fixations. AIDS was initially called “Gay Men’s disease” when it was considered a disease only affecting white gay men. Fortunately, when these disease names were changed, those afflicted with Multiple Sclerosis and AIDS experienced less stigma. Inspired patient activists from around the world are currently engaged in another major effort to rename chronic fatigue syndrome (CFS). It is a political struggle to alleviate some of the stigma caused by the language of scientists at the CDC 25 years ago.

Chronic fatigue syndrome is an illness as debilitating as Type II diabetes mellitus, congestive heart failure, multiple sclerosis, and end-stage renal disease. Yet 95% of individuals seeking medical treatment for CFS reported feelings of estrangement; 85% of clinicians view CFS as a wholly or partially psychiatric disorder; and hundreds of thousands of patients cannot find a single knowledgeable and sympathetic physician to take care of them. Patients believe that the name CFS has contributed to health care providers as well as the general public having negative attitudes towards them. They feel that the word “fatigue” trivializes their illness, as fatigue is generally regarded as a common symptom experienced by many otherwise healthy individuals. Activists add, that if bronchitis or emphysema were called chronic cough syndrome, the results would be a trivialization of those illnesses.

Powerful vested forces have opposed changes. In the late 1990s and early 2000s, when I mentioned over the years that patients were stigmatized by the term chronic fatigue syndrome, I was explicitly told it was reckless and irresponsible to change the name. This was despite the fact that patients wanted more medical-sounding name, and our research group had found that a more medical-sounding term like myalgic encephalopathy (ME) was more likely to influence participants to attribute a physiological cause to the illness.

Over the last decade, patient demands for change have grown louder. New names have occurred for several patient organizations (e.g. the Patient Alliance for Neuroendocrineimmune Disorders Organization for Research and Advocacy and the Myalgic Encephalomyelitis Society of America) and research/clinical settings (Whittemore/Peterson Institute for Neuro-Immune Disease). Even the federal government has begun to use the term ME/CFS, and the organization of researchers changed their name to the International Association of CFS/ME. Ultimately, many activist groups want the term myalgic encephalomyelits to replace CFS. Bringing about a name change is a complicated endeavor, and small variations of language can have significant consequences among the stakeholders.

In addition to this effort to rename chronic fatigue syndrome, there is considerable patient activism to change the case definition, which was arrived at by consensus at the CDC rather than through empirical methods. Patients report and surveys confirm that core symptoms of the illness include post-exertional malaise, memory/concentration problems, or unrefreshing sleep. Yet these fundamental symptoms are not required within the current case definition. Patients want the current case definition to be replaced with one that requires these types of fundamental symptoms. If laboratories in different settings identify samples that are not homogenous, then consistent biological markers will not be found, and then many will continue to believe the illness is one of a psychogenic nature, just as once occurred for multiple sclerosis. Clearly, issues concerning reliability of clinical diagnosis are complex and have important research and practical implications. In order to progress the search for biological markers and effective treatments, essential features of this illness need to be empirically identified to increase the probability that individuals included in samples have the same underlying illness.If progress is to be made on both the name change and an empirical case definition, key gatekeepers including the patients, scientists, clinicians, and government officials will need to work collaboratively and in a transparent way to build a consensus for change. Considerable activity is currently ongoing at the federal level on these critical issues, but only through open communications and the building of trust will there be the possibility of overcoming the past 25 years, which have been marked by feelings of anger and hostility due to being excluded from the decision-making process.

Below are comments submitted to the IOM by Attorney Edward Burmeister* for the public meeting to be held on January 27. Please send your own comments to: mecfsopensession@nas.edu After January 27 you can send comments to: mecfs@nas.edu

And, if you haven't already, you can also sign the petition to cancel the IOM contract and adopt the CCC.

Every email counts. Every signature counts. Every time you speak your mind - it counts. Don't let anybody, or anything, silence you.___________________________________

I am an attorney with the world's largest law firm. My wife, Jeannette Burmeister, is also an attorney who worked at the same firm until she became disabled with ME eight years ago.

I am writing to express, in the strongest terms possible, my objection to the IOM contract to recommend clinical diagnostic criteria for ME/CFS ("IOM Contract").

Moving forward with this IOM Contract is directly against the interests of ME/CFS patients, is in direct opposition to the opinion of 50 ME/CFS experts and is in disregard of the recommendation of the Chronic Fatigue Syndrome Advisory Committee ("CFSAC").

The only reasonable and sensible step to take at this time would be to terminate this ill-advised contract now.

One has to ask the following question:

Why would HHS enter into the IOM Contract for $1 million, 20% of the annual NIH budget for ME/CFS in light of (1) the CFSAC recommendation to convene a stakeholders' meeting of ME/CFS patients, experts and advocates, working in consultation with CFSAC members, to reach a consensus for a case definition for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition, (2) the clearly stated opposition of 50 ME/CFS experts to HHS reaching out to the IOM for developing such criteria and (3) the pitiful lack of any meaningful government funding for ME/CFS?

Moreover, why was this done behind closed doors without consultation with CFSAC, other than notice to its chair?

Add to this question the following:

Why was the IOM Contract entered into quickly and secretly?

To this date, HHS/NIH have refused to release a copy of the IOM Contract and surrounding documentation, despite multiple FOIA requests and an FOIA lawsuit filed by my wife to obtain these documents.

Why the obfuscation by HHS?

In a statement by Dr. Nancy Lee, Designated Federal Officer of HHS to CFSAC, and in FAQs issued by HHS, there is a clear reference to a contract between HHS and the IOM, but in the "National Academics Umbrella Contract Statement of Work/Request for Proposal," released to a patient by HHS, the IOM Contract appears to be a "task order against the NIH umbrella contract" with the National Academies.

Why does this Statement of Work recite that the project to be undertaken by IOM is in support of the Chronic Fatigue Syndrome Advisory Committee (CFSAC), when it runs directly contrary to CFSAC's recommendation?

Why does the proposed IOM committee include a majority of non-ME/CFS experts, as acknowledged by HHS, in a project to develop diagnostic criteria for one of the most complex diseases that exist?

Why is there only one public meeting required under the IOM Contract and why are the IOM recommendations in its final report to NIH to be developed in secret without any opportunity for public or expert comments on the final report?

Why is the IOM the appropriate entity to perform this project given its organizational conflict of interest (the subject of a formal complaint to the HHS Office of Inspector General) presented by its prior ME/CFS findings in its reports on Gulf War Illness and its lack of experience in developing case definitions for diseases, as confirmed by Dr. Kenneth Shine, former president of the IOM.When one ponders these questions, the answers are quick to suggest themselves.

There are key players within HHS who do not want ME/CFS to be elevated to a serious, physical disease demanding substantially increased funding, approval of research grants, approval of disability claims, approval of Medicare claims, etc.

Once the CFSAC recommendation was made in October 2012, these players set in motion a behind-the-scenes process that resulted in the announcement of the IOM Contract in September 2013, without prior public consideration or comment and, as noted above, in direct opposition to ME/CFS experts and CFSAC.

The process has been structured to (1) minimize public and patient input, (2) insure the ME/CFS experts will be in the minority, (3) ensure the final recommendation will be developed in secret without public comment and (4) ensure NIH control of this process through a secret monthly meeting of the IOM with the NIH Task Leader, contrary to the IOM's normal procedures.

If one is skeptical of my conclusions, I would suggest researching the series of IOM reports on Gulf War Illness, where the VA was in the same role HHS/NIH is in the IOM Contract.

I would commend to your reading the testimony of Mr. Anthony Hardie, a Gulf War veteran, given on March 13, 2013 to the House Veteran's Affairs Committee on Oversight and Investigations.

The IOM Contract cannot be "saved" by tinkering around the edges.

In light of the essential facts - (1) NIH control, (2) organizational conflict of interest, (3) majority of non-experts and several IOM "regulars" as committee members and (4) very little by way of public meetings or review, particularly of the ultimate recommendation - the only appropriate course of action is to terminate this contract or task order now before the inevitable damage to the ME/CFS patient community becomes permanent._________________________________

* Mr. Burmeister is listed in Best Lawyers in America, Northern California Super Lawyers and Chambers America’s Leading Lawyers for Business (#1 ranking). In 2011, Mr. Burmeister was recognized as Best Lawyers' San Francisco Employee Benefits Lawyer of the Year.Mr. Burmeister is past Chairman of the State Bar of California - Taxation Section. He is a member of the Advisory Board of the National Association of Stock Plan Professionals, the Certified Equity Professional Institute (past board member), Santa Clara University, and the Global Equity Organization (past board member).Mr. Burmeister is a graduate of Stanford University (A.B.) and Stanford Law School (J.D.) where he was Order of the Coif and Managing Editor of the Stanford Law Review. He is admitted to practice in California and before the U.S. Tax Court and Claims Court.Mr. Burmeister is a veteran of the Vietnam War, having served as a Lieutenant in the U.S. Navy from 1966 through 1970.

On January 27, the IOM will hold its only public meeting regarding its contract to develop diagnostic criteria for ME/CFS. The contract has been hotly contested by ME/CFS advocates, and by physicians and researchers who are experts in the illness. The position taken by 50 of the top experts in the field is that non-experts should not have a say in determining the definition of an illness they know little about. They also point out that a clinical definition has already been developed - the Canadian Consensus Criteria.

More than 100 advocates have supported the experts' position. They have also drawn attention to the fact that the previous IOM case definition for Gulf War Illness was a disaster. (The IOM's definition for "chronic multisymptom illness" is currently being challenged by veterans.) In its report on treatments for "CMI," the IOM stated in the Review of Treatments for Comorbid and Related Conditions that "Two specific therapies are recommended for people who have CFS: CBT and Graded Exercise Therapy (GET)." (You can read the report HERE.)

The ramifications of replacing the current CDC case definition with one that is even worse - along with accompanying recommendations for treatments that are either harmful or useless - make the IOM contract one of the most important challenges the ME/CFS community has ever faced.

Do you have something to say?

Seven people have been invited to make short 10-minute presentations at the meeting (see the list HERE). Fifteen more will have a chance to make 3-minute comments. That's a total of 105 minutes.

Do you think that an hour and 45 minutes is long enough to convey the concerns of more than 17 million ME/CFS patients to the IOM?

I certainly don't.

Fortunately, there is a mechanism for making your concerns known to the IOM committee. You can submit written comments via email - and I strongly encourage you to do so.

Send an email to mecfsopensession@nas.eduPlease focus your comments on the following question:

“What is the most important aspect or information that this committee should consider throughout the course of the study?

Written comments received by January 22, 2014 will be distributed to the committee before the meeting on January 27. After January 27, written comments should be sent to the project email address: mecfs@nas.edu

Don't miss this opportunity to speak your mind. We have been kept silent for too long.

In this interview sponsored by the Dutch ME/CFS Association, Dr. Nigel Speight, a British pediatrician, explains how the medical system has failed young people with ME.

Dr. Speight has been involved in 30 cases in which children with ME have either been forcibly removed from their homes, or threatened with sectioning. In all of these cases, the children - or their mothers - were given a psychiatric diagnosis that replaced their diagnosis of ME.

How did this come about?

According to Dr. Speight, "Once someone pulls the trigger to set child protection proceedings in motion it is like a juggernaut ... it is very difficult to reverse. The further the proceedings go the more the professionals dig in. They cannot afford to lose face, or admit they were wrong. There is an almost sadistic element in the worst cases."

Dr. Speight presents horrifying cases in which parents who resist the psychiatric diagnosis have their children taken from them out of "revenge." Once children are placed in a mental ward, parents may be prohibited from visiting them, increasing the despair, and also worsening the physical condition, of these seriously ill children.

While Dr. Speight has defended 30 children with ME, it is important to keep in mind that the practice of removing physically ill children from their homes on a psychiatric pretext is not limited to these cases.

Justina Pelletier a young girl with mitochodrial disease was removed fro her home and placed under psychiatric care in Boston Children's Hospital for nearly a year. Karina Hansen, a young woman with ME, was forcibly removed from her home in Denmark. There are many other cases as well, ones which do not make the news.

The harm that has been done to these children is, in some cases, irreparable. But, as Dr. Speight has pointed out, there is little hope for defending these children until legal action is taken.

The full transcript below has been provided by the Dutch ME/CFS Association. Copyright ME|cvs Vereniging Wetenschap voor Patiënten (Science to patients) Interview with Dr. Nigel Speight, Broadcast January 7, 2014 I’m Rob Wijbenga, chair of the ME/cfs association in the Netherlands, and I’m a representative for the project Science to Patients. In that function I’m here to talk to Nigel Speight, paediatrician, who has been willing enough to participate in this project and to give six short talks on different aspects of ME/cfs based on questions from patients. Welcome doctor Speight and thank you so much for participating. I believe you have been involved in quite a number of cases where children with ME have been threatened with removal from their families by social services. Could you tell us about this area? Well this is a very painful area. It’s one of the most unpleasant things I witnessed in my entire medical career. It’s something that I’ve seen all over the British Isles, I’ve had cases scattered throughout the map of Great Britain. And they all seem to have similar causes, and a lot of it comes from a simple failure of doctors to protect patients by diagnosing them with ME/cfs. Which then puts them at risk of being persecuted for alternative explanations. I have had about over thirty cases which have all resulted in child protection proceedings with case conferences being held and the threat of removal. Fortunately most of them we have managed to avert by early intervention, giving second opinions. But quite a few have actually, has been a real threat of removal, and one or two children have actually spent time away from their families against their will. Because of court proceedings. Could you tell us about any particular case, which demonstrates this problem? Yes, there is one from an area in the Midlands. We’ll call her Tiffany, it’s not her real name for confidentiality. A lovely 13 year old girl, lively, talented, musical and she was in perfect health until she was struck down with quite acute onset ME, at the age of 13. And she was so ill that her mother had to turn to hospital doctors for admission to hospital. She did this openly and trustingly, and once in hospital she was under a paediatrician who believed in ME and everything seemed all right. But gradually the multi-disciplinary team, including a child psychiatrist, an occupational therapist and a physiotherapist, took over the management of this case. And they set up weekly meetings where the girl was set targets, where she had to reach these targets. And she’d be taken to these meetings in her wheelchair with her head sagging, and have to sit through them and agree to try and achieve the targets next week. She was in hospital for three months, she got steadily worse despite cooperation. The professionals could not tolerate this failure to improve, and they blamed the mother. So the mother’ s visiting was limited till 6 p.m. So the physiotherapist had her all day long. The nurses used to leave her food outside her reach, so she would have to fight to get to it. Whenever her mother came in she found her demoralized and tearful.

Subsequently despite the mothers visiting being limited, the child continued to get worse. The first paediatrician said: “You might as well take her home”, and so the mother took her home. And then the family doctor came and subjected her to 30 minute intense interviews to try to find out what her mental state was and why she was in this state. The girl was reluctant to keep talking to this GP and he reduced her to tears. The family doctor then informed social services that she couldn’t accept responsibility. And social workers came with police and removed this girl from her mother again, and then treated it as a case of Münchhausen syndrome by proxy. Mother’s visiting was restricted to when there was a social worker present. And the plan was to remove her to foster care for six months. And this was the aim that she then would get better, because it was her mother who was making her ill. I was called in by the independent social worker, and met this girl, totally demoralized, resigned going to foster care. And I simply put in the opinion that their management of ME had no evidence to support it, and that it wasn’t the mother’s fault. And fortunately we did manage to get that girl discharged home, after which she made a slow but steady recovery. She has now completed university. So that was a happy ending, but a lot of unnecessary unhappiness on the way. And that was a reasonably typical case that went quite a long way down the line. That was a nice intervention you could say. Well that is the virtue of the independent social worker system. How far down the court system goes there is often a chance for second opinions and to try to oppose these sort of proceedings. I’d like to say I have been successful in 28 out of 30 of the cases I have been involved in. But the two that I have lost have been very unpleasant. That’s marvellous. And do you know of other cases, taken care of by other paediatricians. Yes, I had a case which was similar but different in some ways in which the influence of psychiatry was greater. And this was again a girl of about 13 or 14 in Scotland and she was under the care of a paediatrician who diagnosed ME quite confidently and she was moderate, moderately severe. But then she got more severe and this is one of the risk factors. The severe case of ME is not tolerated by professionals. The paediatrician lost her nerve and referred her to psychiatry who made the alternative diagnosis, not of Münchhausen syndrome by proxy this time, but of a thing called the ‘Pervasive Refusal Syndrome’. It wasn’t a case of pervasive refusal syndrome. She was cooperating, she was just very ill. And by the time I was called in to intervene I found her on a psychiatric ward, curled up in a foetal position, being tube fed and very very sensitive to light and sound. And every time the nurses closed the door a shudder went through this girl’s body. But the psychiatrist would not allow her to have ear protectors because that would increase her sense of withdrawal. And the psychiatrist insisted on talking to her in a loud voice and this way they would cure her of her Pervasive Refusal Syndrome. I’d like to say the court order was reversed a week later and she went to a gentle nursing home where she has been allowed to make a slow but steady recovery. But how you can change from having ME to having a purely psychiatric diagnosis just because you have been handed from a paediatrician to a psychiatrist I don’t really understand. What is your understanding of the factors leading to this state of affairs? I think it is easy to blame the social workers because when they come in what they do seems to be so cruel but I think we actually have to blame the medical profession first. It is the medical profession’s duty to be able to make a confident clear diagnosis of ME/cfs. And if they do that, this should be protection. But many of the cases I have seen have not even be diagnosed and then care proceedings are started by the education authorities for non-school attendance. So doctors have to get it right to start with. The social workers will only get it wrong if the doctors don’t protect the child with a diagnosis. I should say, I have seen a lot of real abuse in my life, and I have been involved in protecting a lot of severely abused children. And to now being on the other side and to see innocent families being persecuted by the social workers who should be protecting other children is remarkable. I once saw a 9 year old boy who was threatened with care proceedings and as part of my assessment I asked him his three wishes. Which is one of the things you do to understand a child’s state of mind. And beautifully he said: ‘ I wish there were better judges and social workers in this world who would do better protecting children who need protection and not troubling families like mine’. And this is a child of nine ??? A child of nine. Out of the mouth of babes and children. I should say that once someone pulls the trigger to set child protection proceedings in motion it is like an ocean liner. It is like a juggernaut. It is very difficult to reverse. You have a social worker who is trained in child protection. They are used to parents protesting their innocence they have to overpower them and they keep going. And the further the proceedings go, the more the professionals dig in and cannot afford to lose face or to admit that they are wrong. I should say I have had one beautiful experience of a social worker who was completely converted by seeing the film ‘Voices from the shadows’ which touches on this, that she became an advocate for the family, refused the psychiatrist’s diagnosis of child abuse and helped them to withstand further pressure. So that film did a lot of good there. Fortunately there are cases like that. There is not much independent thinking in most of the cases, there is a sort of collusion when the whole case conference has met and as one they have voted the same way. They all feel supported by each other. And you don’t see a development for the better in this country? I have got three cases going at the moment and that is not good. How can you explain the spectacle of otherwise caring professionals inflicting what you have described as child abuse by professionals? Dr. Leonard Jason as a social psychologist said very perceptively that as a group professionals can commit acts of cruelty that they would not be capable of as individuals. But somehow their kind of self-righteousness of a cut case conference, all agreeing together allows them to proceed down these lines. I keep yearning for there to be a little boy who says ‘the emperor’s got no clothes on’, but there’s a lack of independent thinking in the process. So once the process starts it’s very hard to reverse. I’m just astonished at how few doctors can confidently diagnose ME/cfs and protect children. I say I’m only seeing the bad cases. Maybe lots of children are being protected. The educationalists have a pressure on them to ensure school attendance. So if children aren’t protected by a diagnosis they will set the motion going. I sometimes think the child-protection social workers who are handling these innocent families are relieved to have such a soft target. Because most of the time their families are very tough to deal with. And if I was a social worker in child-protection I would much prefer to be drinking tea with a respectable innocent family and just taking one or two years of my time over it, than going to a house where my tires were slashed and I was threatened by Alsatians. But I have to say there is something once the whole process gets going, there is a kind of almost sadistic element to some of the worst cases. They must be able to see the suffering they are causing. And so often as a group the professionals fail to actually speak to the child who is usually quite old enough to tell them their opinion and to put them right. And if you talk to the child it all comes straight. I sometimes think we should make a dossier of all the cases. I haven’t got round to it but we should take it to people in parliament and colleges and paediatrics and everywhere because it is not getting better at the moment. So you don’t see any change of attitude at all? I sometimes feel it is getting worse. And then you talk about a group of psychology who is at work. Everybody feels supported by the unanimity of the club. Yes. So you see independent psychologists who are driven along with this current.

I have seen quite a few cases where the fact that the family have declined the help of a psychiatrist has led to the child protection proceedings. The psychiatrists have felt rejected and have instituted child protection proceedings almost as a revenge. I should say there is another aspect to all this which sometimes comes more from paediatricians, and this is doctors who believe in their therapies. Whether it is graded exercise or cognitive behavioural therapy. And if it is a severe case and they can’t travel, the families are accused of ignoring medical recommendations. Now adults can do that, but parents refusing on behalf of their child instantly makes the paediatrician say they are refusing medical advice, this is child abuse. So this is more or less a law…? Yes. Well it is the false believe that they have got effective treatments. So often these treatments, the physiotherapy actually make the children worse. Can you think of anything which will cause, let’s say a new way of thinking? Which tools are available right now to help to effectuate that, if there is any? I have great difficulty thinking of anything at the moment. There is nothing actually happening. Maybe that a cure is found then the doctors will get ME right and the social workers won’t have any referrals. But we need something dramatic to happen. Another possibility is that some families actually take legal proceedings against the professionals and begin to counterattack. But I think most of them are so downtrodden and are so frightened of further action that’s beyond them. So at the moment I am still quite pessimistic. Thank you so much for participating.

This lawsuit is the culmination of Jeannette Burmeister's efforts over the past four months to gain access to documents regarding the IOM contract through the Freedom of Information Act. The FOIA gives citizens the right to access information from the federal government, which includes HHS.Jeannette Burmeister received her law degree from the Berlin School of Law and her Master of Law degree from the University of San Francisco School of Law. She was a former attorney at Baker & McKenzie, a global law firm employing over 4,100 lawyers in 46 countries.

Reprinted with permission from Jeannette Burmeister and Thoughts About ME._____________________________

By Jeannette Burmeister

Today, I filed a lawsuit against HHS and NIH in the U.S. District Court for the Northern District of California for failure to comply with the requirements of the Freedom of Information Act (FOIA) regarding documents I requested relating to the Institute of Medicine (IOM) “study” of diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome. I have asked for my costs and attorney’s fees. The complaint can be found at this link.

I am not claiming that this is the only time a government agency has failed to comply with the FOIA. However, this case seems particularly appalling given its context:

Patients with this disease have been harmed, dismissed, ridiculed, abused, neglected and completely abandoned by the government, and as a result, by the medical profession, insurance companies, friends, family, neighbors, colleagues; in other words, by society at large. This is largely due to the unscientific government-sponsored case definitions, another one of which was ordered from the IOM, which is the issue at the heart of my FOIA request. In light of this crucial reality, it simply boggles the mind that the government would arrogantly ignore their duties under the FOIA.

The IOM “study” is a highly contentious issue and the secrecy game the government is playing at the expense of violating federal law leads many to believe that the government has something to hide. It certainly isn’t worried about giving that impression.

At least two other patients have filed FOIA requests similar to mine.

The documents requested are readily available to the government, as they have been publicly referred to by HHS and quite frankly, it’s callous to force patients to have to go to the effort of filing FOIA requests given the toll that takes on their health.

I followed up on my initial request 3 times and I sent one last letter to the government 5 days ago warning them that my lawsuit is imminent if they don’t comply immediately.

I don’t understand why other patients find this kind of mistreatment acceptable and continue to seek a seat at the table when it is clear that the game played at the table is rigged (to borrow Lisa Petrison’s terms). The government feels comfortable violating federal rights of patients for whom they should go above and beyond at this point to atone for their decades of abuse. Yet, the opposite is true. What will it take for people to see that the bureaucrats will not move an inch, unless we make them by suing them or by making them look bad in public? Cooperation clearly hasn’t worked for us because doing the right thing is not a variable that factors into the equation for the government. Remember, the best predictor of future behavior is past behavior, especially when there is a clear indication, as there is here, that somebody, the government, is doubling down on their prior infractions.Complying with our clear and basic federal rights is about the least respect towards the patients the government should be able to muster. Looking at these facts, one can only guess the level of disgust the government must have for us patients. I have heard from many patients that the feeling is mutual at this point._______________________________Jeannette Burmeister received her law degree at the Berlin School of Law and her Master of Law degree at the University of San Francisco School of Law. She was a former attorney at Baker & McKenzie, a global law firm employing over 4,100 lawyers in 46 countries. Atty Burmeister is licensed to practice law in California and the United States. She was disabled by ME at the age of 34. Atty Burmeister is a dedicated patient advocate and blogs regularly about matters concerning the ME/CFS community on Thoughts About ME.

The following post by Jennie Spotila appeared today on Occupy CFS. It speaks to the secrecy with which the federal government has surrounded all issues pertaining to ME/CFS.

In this instance, the National Institutes of Health (the agency charged with funding nearly all significant medical research in the country) has convened a workshop - essentially a literature review - to provide the material upon which a definition for the illness will be made.

Significantly, the workshop is not open to the public, nor does it include any ME/CFS experts. There can be only one reason for barring input from the people who know the most about the disease: What they intend to say will not be to our benefit.

Click here to contact the P2P program. Ask who the panelists are, what the results of the workshop will be used for, and if there is to be any public input.

Reprinted with permission.___________________________

By Jennie Spotila

There’s an important meeting happening at NIH today and tomorrow, but you probably know nothing about it. The secrecy of this meeting is intentional, and the implications of decisions made at the meeting are as far-reaching as the Institute of Medicine study. In fact, what I’ve learned about the meeting may strike you as worse than the IOM study process.

Short Version

The P2P Working Group roster has not been made public.

The P2P Working Group will finalize the study questions for the evidence review and workshop.

I can exclusively reveal who was contracted to conduct that evidence review.

I can exclusively reveal the draft study questions.

The P2P panel, which will conduct the Workshop and write its report, will be 100% non-ME/CFS experts.

What Meeting Is This?

January 6-7th is the first meeting of the Working Group for the Pathways to Prevention Workshop on ME/CFS. You may be more familiar with the old name for the meeting, the NIH Evidence-based Methodology Workshop. At the May 2013 CFS Advisory Committee meeting, Dr. Susan Maier clarified the purpose of the Workshop “is to identify methodological and scientific weaknesses in a scientific area and move the field forward through the unbiased and evidence-based assessment of a very complex clinical issue.” The Workshop itself will not create a research definition for ME/CFS, but Dr. Nancy Lee said that the output of the workshop could be used to inform such a definition. (CFSAC Minutes, May 23, 2013, pp. 6, 48-49)

The Pathways to Prevention Program (P2P) is operated through NIH’s Office of Disease Prevention. Each workshop process takes about a year from start to finish, and its foundation is a technical brief providing “an objective description of the state of the science, a summary of ongoing research, and information on research needs.” This brief is prepared by one of the Agency for Healthcare Research and Quality’s (AHRQ) Evidence-based Practice Centers (EPC).

At today’s meeting, the Working Group will finalize the study questions that frame the entire workshop process. Obviously, the questions are of critical importance since they form the basis for the evidence review and technical brief, as well as the public workshop itself. But before we get to the questions, don’t you want to know who is on the Working Group?

Who Is On This Working Group?

Guess what? We don’t know. At the May 2013 CFSAC meeting, Dr. Maier reported that 35-40 potential names were forwarded to the Office of Disease Prevention for possible service on the Working Group. She said that the list included ME/CFS experts, advocates and patients, including some CFSAC members. Despite vigorous objections expressed by Dr. Mary Ann Fletcher, Dr. Maier did not share the list, did not allow CFSAC to provide input, nor did she indicate a timeline for the release of that roster. (CFSAC Minutes, May 23, 2013, pp. 8, 49)

Unfortunately, Dr. Maier also did not provide the roster at the December 2013 CFSAC meeting and, to my dismay, no one on CFSAC asked her about it. Dr. Maier has also refused an individual request for the roster prior to the meeting, citing “standard procedure,” and there is no indication whether or when that information will be made public.

Why is this a big deal? Because the Working Group helps shape the entire workshop process. According to the P2P site, “the Working Group is involved from the beginning to the end of the workshop planning process; it finalizes the questions that frame the workshop, nominates panelists and speakers, and selects the date of the workshop.” Interestingly, the Working Group is made up of “content area experts from the federal government, academia, and clinical practice.” Dr. Maier said the nomination list included advocates and patients, but we have no way of knowing if any were actually appointed to the Working Group.

The Study Questions

Dr. Beth Collins Sharp described the evidence review process in detail at the May 2013 CFSAC meeting. One of the AHRQ EPCs is contracted to conduct a comprehensive evidence review based on study questions. Those study questions were drafted by unknown federal employees, and are finalized with the input of the Working Group, the EPC and federal participants. This is happening today and tomorrow.

As Dr. Collins-Sharp said in May, “You can’t get the right answer if you don’t ask the right questions.” (CFSAC Minutes, May 23, 2013, p. 12) However, Drs. Maier and Collins-Sharp have refused an individual request for the study questions being presented to the Working Group today, and have said only that the final questions will be posted by AHRQ and ODP but provided no timeline for this. Incidentally, they have also refused to disclose which EPC was contracted to perform this review.

However, I can answer both those questions today because I obtained a copy of the EPC task order through FOIA. The “Small Systematic Review for Diagnosis and Treatment of Myalgic Encephalophyelitis/Chronic Fatigue Syndrome (ME/CFS)” will be conducted by the Oregon Health & Science University for $358,211. I will discuss this contract in more detail in a future post. For now, I draw your attention to the draft questions as stated in the Task Order, and presumably being presented to the Working Group today:

I. How do ME and CFS differ? Do these illnesses lie along the same continuum of severity or are they entirely separate with common symptoms? What makes them different, what makes them the same? What is lacking in each case definition – do the non-overlapping elements of each case definition identify a subset of illnesses or do they encompass the entirety of the population?

II. What tools and measurements will help define the subsets of individuals in the entire spectrum on ME/CFS? Are some of these tools already available and can they reliably detect a subset of illnesses? Is it possible to identify which subset of individuals is not defined by the current tools and measurements? What is unique about the illness quality in those individuals not captured by the tools available?

III. What are the characteristics of the individuals who respond to specific treatments in terms of the spectrum of the disorder? Why do some individuals not respond? What aspect of the disorder is most relieved by specific treatments? For treatments that have been shown to be effective, what are (is) the underlying mechanism(s) of action of that intervention?

IV. What does clinical research on ME/CFS tell us about clinical diagnosis of ME/CFS? Are there hints in the current literature for a consistent defining characteristic? In the clinical realm, what differentiates borderline “cases” into confirmed versus probable? Do co-morbidities help define subsets of the clinical cases?

V. Have previous research findings shaped current clinical practice or are research and clinical practice completely separate with respect to the illness? How much influence does biomedical research help shape [sic] the future of ME/CFS research?

There are so many issues with this list. For starters:

Asking whether ME and CFS differ is critical (I), but this question fails to ask whether the mixed bag of “CFS” is even a valid clinical entity to begin with. It’s also important to note that the remainder of the questions (II-V) revert to lumping ME and CFS back together as one illness.

Question II asks what tools/measurements can be used to identify subsets along the whole spectrum, i.e. NOT whether such a “subset” actually represents a separate illness. It also asks if there is a subset not defined by current tools and measurements. Huh? How could a subset be identified if there are no tools/measurements to identify them?

Question III, the characteristics of patients who do or do not respond to treatment, rests in part on case definition. Will a systematic review dig into the raw data on studies such as the PACE trial or Ampligen trials to identify characteristics of responders and non-responders? Can applicable case definitions in those study cohorts even be assessed retrospectively (e.g. to examine a Fukuda cohort to see how many met the Canadian criteria)? Will the systematic review treat studies with different case definitions as equivalent (e.g. Oxford studies are as valid and relevant as Fukuda studies)?

Question IV strikes me as the question actually being posed in the IOM study. The IOM will be identifying the evidence for various diagnostic criteria, and then develop evidence-based clinical diagnostic criteria. Including the same type of question here seems needlessly duplicative. And what if the two evidence reviews come up with different answers?

Finally, I can answer Question V myself: it’s both. There are a number of key clinician-researchers who maintain a clinical ME/CFS practice and conduct research. For those individuals, their research influences their clinical care and vice versa. But for the rest of the world, we know that clinical care is completely divorced from ME/CFS research. Based on the horror stories we hear from patients, based on the dramatic under-diagnosis of the disease and simultaneous use of CFS as a wastebasket diagnosis, I think it is abundantly clear that research and clinical practice is separated by a great wall for most patients.The Working Group’s planning appears to be closed to the public, and we have no input onto the final questions. We wouldn’t even have this draft list if I had not managed to file a successful FOIA request. The anonymous Working Group will finalize the questions, and these will be posted publicly – although we have no timeline for that.

Non-Experts By Design

Supposedly, the Working Group is made up of ME/CFS experts. That’s the impression Dr. Maier gave at the May 2013 meeting, and by the P2P website. But the P2P Panel is a completely different story.

The P2P Panelists perform several functions: review the evidence report produced by the AHRQ review; attend a pre-Workshop webinar to discuss the evidence report and additional materials; attend the Workshop and ask questions of the presenters; prepare a draft panel report; and review and incorporate public comments to finalize the report.

Panelists can be nominated by members of the Working Group BUT there are significant restrictions on their expertise. Specifically, the panelists:

May be knowledgeable about the general topic under consideration, but must not have published on or have a publicly-stated opinion on the topic.

Must not have intellectual conflicts, such as participation in statements by professional societies or participation in advocacy groups on the topic.

Must not hold financial or career (research) interests in the workshop topic.

Let’s be very clear about what this means. If someone has ever published on or made a public statement about the diagnosis and treatment of ME/CFS, he/she is disqualified. If someone has participated in statements from professional societies or participated in advocacy groups, he/she is disqualified. If someone has a financial or research interest in the diagnosis and treatment of ME/CFS, he/she is disqualified. Furthermore, there is no public comment period on the panel roster like there was for the IOM panel. In fact, it’s not even clear to me how far in advance we will know who has been appointed to the panel.

If the IOM process makes you mad, then this process should make you furious. There will be no ME/CFS experts on the panel that writes the Workshop report identifying methodological and scientific weakness in ME/CFS, suggesting research needs, and providing “an unbiased, evidence-based assessment of a complex public health issue.” The only involvement of experts will be through the Working Group and through the presentations made at the Workshop. I only see one upside to this arrangement: anyone who has been associated with the psychogenic model of ME/CFS will also be excluded.

This process may work very well for the “generally noncontroversial topics” that P2P is designed to address. For example, I can easily imagine the benefit of non-experts examining the state of research for a rare genetic disease. Only one other disease has been examined through P2P: polycystic ovary syndrome. The P2P workshop examined the current diagnostic criteria, causes and risk factors, and prevention and treatment strategies. There were only four panel members: an obstetrician-gynecologist, a cardiologist, the executive director of the American College of Nurse-Midwives, and the Executive Dean for Research at the Mayo Clinic. No patients or advocates spoke at this Workshop. It is not clear to me how well received the panel’s recommendations were in the PCOS patient community.

There are obvious problems with trying to apply this process in ME/CFS. First, there is no single body system to focus upon. While the PCOS Workshop could draw on endocrinologists, gynecologists and women’s health experts, what is the specialty pool for ME/CFS? Second, it is well known, and I believe generally accepted, that doctors and researchers without ME/CFS expertise will still have preconceptions about the disease. We need look no further than FDA for an example. It wasn’t until after the four-hour active listening session in April 2013 that FDA representatives, by their own admission, began to understand the seriousness of the disease, and this was a group of people who were familiar with ME/CFS to some extent. If the P2P panel is comprised of people with little ME/CFS knowledge and possibly negative preconceptions, and the Workshop does not include significant participation from ME/CFS patients and advocates, it seems unlikely that the best results will be achieved. Based on our decades of experience with misinformed scientists, clinicians, and policy makers, it is very hard to trust in such a process.

Bottom Line

Almost the entire process of this Workshop is being conducted behind closed doors. The Working Group roster has not been released. The Working Group meeting is not open to the public. The draft questions were obtained only through a FOIA. There is no information about when the final questions will be posted. We have no idea who will be on the Panel, or even who will make that decision. And the only way ME/CFS experts are likely to participate is through the Working Group (IF there are any on the Working Group) and through presentations at the meeting. The extent to which members of the public will be able to participate is completely unclear.

So if you are worried about the lack of ME/CFS experts on the IOM panel, or if you think that the public will not have a sufficient opportunity to participate in the IOM process, pay attention! The NIH P2P process looks even worse. We cannot lose sight of the forest for the trees, and IOM is not the only moving piece on this chessboard.

What can we do? I believe that advocates must demand more information about the P2P Workshop, and must demand meaningful opportunities to participate. The planning and execution of the Workshop should be transparent if it is to have any legitimacy in the advocacy community. I urge you to participate in both the IOM and P2P processes at every opportunity – ask questions, provide input, and present a united front based on the truths we know about ME/CFS. We cannot wait until the end of the P2P process to make our voices heard, especially since this process will provide input into the IOM study.

Every once in a while, life gives us a lesson that we will never forget. Mine came on May 6, 1971, in Boston.

On that morning over 3,000 anti-war demonstrators gathered at the JFK Federal Building for a nonviolent sit-down demonstration. We were protesting the mining of the harbors in Vietnam, or perhaps the bombing of Cambodia. I don't remember which, but it was important enough for me to consider doing something public.

The group that had organized the demonstration, the People's Coalition for Peace and Justice, held workshops the previous night to train us in nonviolent protest. The idea was that we were to block the nine entrances to the building by the simple act of sitting down. If anybody tried to remove us, we were to go limp. We were instructed to wear light clothing (T-shirt and jeans), and to put a dime in our shoes. (For the telephone call in case we were arrested.)The leaders of the demonstration had cooperated with the Boston police, and assured them that this was to be a peaceful demonstration, unlike so many others around the country. At the suggestion of the police, the leaders wore armbands, so that both police and protesters could identify those in charge. This would help maintain order.

As planned, we left our gathering places that morning and walked in an orderly fashion to the federal building. There, we were met by several hundred riot police in full gear.

First, they arrested our leaders, who were easily identified by their armbands. Then, they set their dogs on us. Then they hit us over the head with 3-foot billy clubs. They maced us, flung us into the air like rag dolls, dragged us off bleeding, and, finally, they arrested anyone they hadn't already knocked unconscious. I never got to use my dime, because they didn't let me make my phone call. They just threw me in jail.

There is a moral to this story. Actually, there are two. The first is that you can't negotiate with people who intend to kill you. The second is you can't negotiate from a position of weakness.The protest leaders placed us in a position of weakness by negotiating away the only weapon we had. We had numbers, and the potential to cause disruption. They had more weapons, lethal ones, but even with those weapons they could not have overcome 3,000 people - if those people had not cooperated.

I look upon the IOM contract, and indeed upon most of what the federal government has said and done to us over the last 30 years, as a battle. Some of us believe that by cooperating, by playing by the rules they have set down for us, by showing them that we can go limp, they will give us what we want.

That will never happen, simply because people without power never get what they want by going limp. Especially not during a battle. The way people with no power, no money, and no authority get what they want is by refusing to negotiate, by refusing to shut up, and by creating the disruption of "business as usual" through the application of constant pressure.

There are a million people with "CFS" in the U.S. More than 17 million with ME worldwide. Our resolution for the New Year should be to make sure that the people who put Karina Hansen in a psych ward hear us. That those who deny us medical care hear us. That those who bully and threaten our advocates hear us. That those who strip us of our rights while telling us they "feel our pain" hear us. That those who steal our funds, and blacklist our doctors, who turn a deaf ear to our pleas for help, and who belittle, dismiss and ignore us - hear us.There is power in numbers. And a million is a big number.

We will remember 2013 for all we tried to accomplish. Let's make them remember 2014 for all we did accomplish.

With four major conferences held in the US, the UK, and Australia, the inauguration of two new research and treatment centers, the first FDA meeting to discuss drug development for ME/CFS, fireworks at the CFSAC, the still unabated IOM controversy, an unprecedented consensus from the top 50 ME/CFS experts, two exciting new documentary projects, and an upsurge in advocacy efforts, this has been a year to remember.

Meetings: FDA Developments and Fireworks at CFSAC

The FDA held its first ever ME/CFS workshop, Drug Development for Myalgic Encephalomyelitis Chronic Fatigue Syndrome (ME and CFS), April 26 and 27, 2013 in Washington, D.C. The first day of the meeting was titled “Disease Symptoms and Daily Impacts That Matter Most to Patients” and featured presentations by patients, including Dr. Jon Kaiser, Joseph Landson, Charlotte Von Salis, Tasha Kelemen, Matina Nicholson, Mary Schweitzer, Mindy Kitei, and many others. Patient advocates Mary Dimmock, Dr. Janet Smith and Denise Lopez-Majano also described how the illness has affected their family and friends. ME/CFS physicians and researchers Dr. James Baraniuk, Dr. Charles Lapp, Dr. Steven Lempert, Dr. Judy Mikovits, Dr. Derek Enlander and Dr. Dan Peterson addressed the necessity of developing treatments, even if the cause remains unidentified. (You can read about the first day of the FDA workshop HERE.)

The second day of the FDA development workshop for ME/CFS focused on clinical trial design, outcome measures, regulatory issues and possible pathways to expedite drug development for CFS and ME, as well as the development of clinical trials. (You can read about the second day of the FDA workshop HERE and HERE.)The May 22-23 CFS Advisory Committee (CFSAC) meeting was held, as usual, in Washington, D.C. The meeting, which was streamed live, was chaired by Gailen Marshall, and attended by Wanda Jones, former chair of the committee, Kim McCleary, CEO of the CFIDS Association of America, Fred Friedberg, president of the International Association of CFS, Ken Friedman, representing the New Jersey CFS Association, Ermias Belay of the CDC, Susan Maier of the NIH, Theresa Michele of the FDA, Mary Ann Fletcher, Dane Cook, Steve Krafchick, and Eileen Holderman, among others. While the first day revolved around ongoing government projects, such as the CDC’s multi-site study, the second day of the meeting produced fireworks when voting member Eileen Holderman accused the Designated Federal Officer, Nancy Lee, of intimidation. The negative publicity generated by Ms. Holderman’s (and Ms. Mary Ann Fletcher’s) contention that they had been bullied and threatened with expulsion for stating their views ultimately led to the demotion of the fall CFSAC meeting to a webinar.

On May 31st, Invest in ME, a UK charity, held its 8th annual conference to explore biomedical research into ME. This year's conference, titled "Mainstreaming ME Research: Infections, Immunity and Myalgic Encephalomyelitis,” featured a roster of noted physicians and researchers: Dan Peterson and Andreas Kogelnik, who shared the keynote address; Mady Hornig on pathogen discovery in ME; Olav Mella and Oystein Fluge speaking about Rituximab, and more. (For a full program of presentations go HERE. Read Mark Berry's excellent report on this fascinating conference HERE.)Hemispherx Biopharma, the makers of Ampligen, sponsored a conference at the New York Academy of Medicine on "Diagnosis, Treatments and New Developments in ME and CFS" on November 20th. Speakers included Dr. Nancy Klimas, Institute for Neuro Immune Medicine at Nova Southeastern University; Dr. Daniel Peterson, Sierra Internal Medicine; Dr. Judy Mikovits, Dr. Eric Schadt, Institute for Genomics and MultiScale Biology at Mount Sinai Hospital; and Dr. Derek Enlander. The Q&A panel included Dr. Francis Ruscetti, National Institute of Health and Dr. Christian Becker, Critical Care Medicine in New York. Regrettably, the conference was not filmed.

Advocacy Efforts2013 was a very busy year for advocates. The year started with a bang when Bob Miller began a 12-day hunger strike over the FDA’s continued refusal to approve Ampligen, the only ME/CFS pharmaceutical medication that has ever been in clinical trials. Bob, who himself is taking Ampligen, also delivered a petition with 3,890 signatures to the FDA and Secretary of Health seeking Ampligen’s approval. Bob ended his hunger strike on February 10th, after receiving the assurance of Wanda Jones at the Assistant Secretary of Health’s office that Secretary Sebelius would make a serious commitment to address the unmet needs of the ME/CFS community. Ampligen was not approved.

The secret attempt of CSFAC in January to shorten (and alter) the wording of the list of priorities led Jennie Spotila to contact Public Citizen, a watchdog non-profit that has litigated cases under FACA in the past. Public Citizen sent a letter of protest to the Acting General Counsel of HHS on February 14, 2013. The letter points out that the FACA violations deprived “ Ms. Spotila and the public generally of important rights to write a letter calling for an immediate investigation into threats made against three members of the CFS Advisory Committee (CFSAC).observe and participate in the advisory committee process.” Public Citizen asked that the General Counsel “act to ensure that CFSAC complies with FACA and with its own charter going forward.

Despite Jennie’s worthy attempts at setting CFSAC on a straight course, it continued to veer into questionable political territory when, in May, Eileen Holderman and other CFSAC members reported harassment by Nancy Lee, the Designated Federal Officer. This prompted twelve ME/CFS patient organizations and 23 patient advocates to HHS dealt with the demand for an investigation with characteristic torpor. After more than four months, Assistant Secretary Dr. Howard Koh finally responded to the request for an investigation with the statement that “Dr. Nancy C. Lee has authority to engage in private conversations with individual members of CFSAC.” After finding Dr. Koh’s letter “completely unacceptable,” Mary Dimmock wrote a second letter to HHS demanding an investigation. As of this writing, the matter is still unresolved.In similar fashion to its highhanded treatment of CFSAC complaints, over Labor Day weekend HHS announced that it would be contracting the IOM to devise a new case definition for CFS. Given the IOM’s previous history of mishandling the definition of Gulf War Illness (relabeled as “Chronic Multi-System Illness"), advocates immediately demanded that the contract be rescinded, as did 50 of the top international experts in the illness. Over 6,000 people signed two petitions calling for the cancellation of the IOM contract and the adoption of the Canadian Consensus Criteria. The experts’ letter marks what can only be called a sea change in the relationship between advocates and clinicians. For the first time, the two groups stood united in their criticism of the way HHS has historically treated the ME/CFS community. They were also united by their goal, the immediate adoption of the Canadian Consensus Criteria. By the end of 2013, the controversy still has not abated, and it promises to extend well into 2014.At the end of 2013, I am sad to report that Karina Hansen, a 24-year-old severely ill ME patient, is still incarcerated in a psych ward in Hammel Neurocenter in Denmark. On Feb 12th, 2013, five policemen from Holstebro county, Denmark, came to Karina’s house and forcibly removed her from her bed. She was then taken to Hammel Neurocenter, where she is being treated for “psychosomatic illness” with CBT and exercise by psychiatrist Nils Balle Christensen. After almost nine months of daily “rehabilitation,” Karina is still not able to walk. Nils Balle Christensen has declared Karina incompetent in any matters regarding her treatment, and has banned her parents from visiting her. (The case of Justina Pelletier, a 15-year-old with mitochondrial disease who has been confined to a psych ward at Boston Children’s Hospital, bears remarkable similarity to Karina Hansen’s story.) In their most recent public statement, Karina’s parents said that “Karina has become an involuntary guinea pig for psychiatry.”

New Research and Treatment CentersOn February 12th, Nova Southeastern University’s College of Osteopathic Medicine held a grand opening for America’s first Institute for Neuro Immune Medicine. The Institute, directed by Nancy Klimas, is the only one of its kind in the United States that treats patients with CFS/ME and Gulf War Illness (GWI), as well as conducting basic and clinical research under one roof. The Institute is the first in the nation to study neuroinflammatory and neurodegenerative disorders such as CFS/ME, GWI, Parkinson’s Disease and multiple sclerosis using the newest genomic techniques. “We have created a one-of-a-kind think tank that will become the leading neuro immune medicine institute of its kind in the United States,” said Nancy Klimas, M.D. (Read the announcement HERE.)

Griffith University (Australia) opened a new facility, the National Centre for Neuroimmunology and Emerging Diseases (NCNED), on December 2nd. The new center, directed by one of the world’s foremost experts on CFS/ME, Professor Sonya Marshall-Gradisnik, is dedicated to researching the interactions between the nervous system and the immune system. In February 2014 the center plans to open a specialized CFS/ME Clinic. The facility will provide treatment for patients with the illness, and will build on the research being conducted at the center.

New ME/CFS Film Projects

Ryan Prior’s documentary film project, The Blue Ribbon: ME/CFS and the Future of Medicine, garnered over $17,000 on Kickstarter. The idea for the film began with a story Ryan wrote for USA TODAY about his own struggle with ME/CFS over the last 6 years. The response to the article was dramatic, prompting Ryan to embark on a film that would tell the stories of the many people suffering from this illness. To support his film, Ryan launched the Blue Ribbon Foundation, which aims to raise money for the completion and distribution of his film.

Jennifer Brea, winner of ProHealth’s 2013 Advocate of the Year Award, raised an impressive $210,000 for her full-length documentary, Canary in a Coal Mine. Her project also won Tribeca’s Project of the Month for November. Jennifer contracted ME/CFS while finishing her doctorate at Harvard. Her background in political science and statistics prompted her to investigate the illness, and to question the prevailing attitude in medicine that it is a disease that has no cause, no cure, and no explanation. Jennifer hopes that to convince clinicians and researchers that this is not only a serious illness worthy of their attention, but, in her words, “it’s also a fascinating puzzle.”

Prediction for 2014

2013 was a year we will all remember, because it was marked by rising expectations. The FDA meetings seemed to signal a renewed interest on the part of the federal government to help ME/CFS patients in our quest for effective treatment, as did the acknowledgment that it was a serious and debilitating disease. The building – and dashing – of those expectations has sparked an outpouring of advocacy efforts unprecedented in recent years. Jeannette Burmeister’s call for the approval of Ampligen, citing “unequal treatment” regarding FDA’s rapid approval of Bexsero vaccine for a Princeton students, is another step along the path we will surely continue to take in 2014.

My prediction for 2014 is that it will be the “Year of the Advocate.” 2014 marks the 30-year anniversary of the Incline Village outbreak, the epidemic that saddled us with the name “chronic fatigue syndrome.” It is clear that those who have been ill since the 1980s have run out of patience. Cort Johnson’s recent analysis of HHS’s lack of commitment to people with ME/CFS is a harbinger of things to come. In the following months there will be more protests, more petitions, more demands for funding, and more exposes of government neglect.

What is truly astonishing, is that after 30 years of being blacklisted, after watching our young people with ME thrown into psych wards, after having research funds “redirected,” after the insults, the derision, the blatant dismissal of an illness which has robbed us of our lives – we are still here, still fighting to make our voices heard … still undefeated.

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About me:I'm a 25-year veteran of CFIDS. I know what it is like to be bedbound for long stretches of time. I also know what it is like to recover, and to relapse. But this blog is not about my personal experience. It is intended to be a resource - a collection of anything that might be helpful to the CFIDS community: book reviews, advice, CFIDS news, research, advocacy, opinion, who's who in our community, fundraising... and occasionally a bit of humor.

Disclaimer: I am not a doctor, which means nothing I write, no matter how sensible it may be, should be interpreted as medical advice.